Pentax C2 CryoBalloon Mode D'emploi page 4

Directions for Use
This device should only be used by a medical professional
authorized to perform endoscopy and only at a medical
facility.
Contraindications
There are no known contraindications for use of this device.
Reported contraindications for endoscopic use of cryosurgical
ablation devices include:

Pregnancy

Significant ulceration of the target tissue

Narrowing of the access oesophagus lumen that precludes
advancing the C2 CryoBalloon Catheter to the site of
ablation

Target tissue varices at risk for bleeding

Prior Heller myotomy
Warnings

The C2 CryoBalloon™ Catheter is intended for single
patient use only. Do not resterilize or reuse.
Resterilization or reuse may compromise device
performance and increase the risk of cross contamination
due to inappropriate reprocessing, resulting in damage to
the device or patient injury.

Known risks related to endoscopic cryoblation are:
o
Dysphagia
o
Stricture
o
Bleeding
o
Perforation/Oesophageal Tear
o
Mucosal Laceration
o
Pain

If there is resistance during manipulation of the Catheter,
determine the cause of the resistance before proceeding.

Use the device prior to the Use By date specified on the
package.

If the Catheter shaft is bent or kinked, discard and replace
the device. Do not use or attempt to straighten. This may
result in damage to the device or patient injury.

Use only the C2 CryoBalloon™ Cartridge. Device
operation will be impaired if other refrigerants or gases
are used.

The pressure inside the C2 CryoBalloon™ Cartridge is 50
atm. Carefully remove the Cartridge to avoid unintended
release of residual cryogenic fluid from the Controller.
The cryogenic fluid may freeze the skin.

Do not inhale nitrous oxide from the cryogen Cartridge.
Inhalation may be dangerous to your health.

If using the Pear balloon, do not ablate tissue adjacent to
the larger balloon diameter that is not clearly visualized

WARNING: No modification of this equipment is
allowed.
LBL-1045 Rev 12

WARNING: To avoid risk of electric shock, this
equipment must only be connected to a supply mains with
protective earth.

Long term (≥ 2yrs) safety and effectiveness of the
cryoablation of the esophageal dysplasia as an
intervention to prevent development into esophageal
carcinoma remains uncertain.
Precautions

A thorough understanding of the principles, clinical
applications and risks associated with ablation of
unwanted tissue is necessary before using this product.

Use of the C2 CryoBalloon™ Ablation System for
procedures other than those indicated in these instructions
is not recommended.

Multiple ablations at the same site may result in deeper
than intended ablation. In the event that adjacent ablations
are desired, wait until visible ice is no longer present near
the adjacent ablation area.

The C2 CryoBalloon™ Ablation System is designed to be
used in patients with oesophageal lumen diameters
measuring 20 mm to 30 mm. Ablation in larger or smaller
oesophageal lumens is not recommended.

Do not use if package is open or damaged.

Prior to use, examine for defects such as breaks, tears,
bends or kinks. Do not use if defects are found.

Do not pre-inflate or pre-test balloon prior to introduction
through endoscope.

Do not attempt to refold balloon into the protective
sheath.

If the Control Panel on the C2 CryoBalloon™ Controller
does not illuminate after it is plugged into the Foot Pedal
interconnect cable, replace the Controller.

After the procedure, straighten the distal end of the
endoscope as much as possible prior to removing the C2
CryoBalloon™ Catheter from the endoscope. Any excess
bends of the endoscope will increase the resistance during
withdrawal. If there is excessive resistance, remove the
endoscope and Catheter as a unit.

Under normal use, the balloon probe is the only element
of the C2 CryoBalloon™ Ablation System that will be
o
0 C or colder. If any of the user accessible components
are excessively cold, discontinue use.

The C2 CryoBalloon™ Controller heater assembly
contains a thermal protector to protect against
temperatures in excess of 100
reached, the thermal protector will render the Controller
unusable.

The C2 CryoBalloon™ Controller is considered IPX0 (no
protection, do not immerse in liquids) for ingress
protection against liquids.

The C2 CryoBalloon™ Foot Pedal meets IPX6
(protection against water rinsing, do not immerse in
liquids) for ingress protection against liquids.
PENTAX Medical
° C. If this temperature is
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