Pentax C2 CryoBalloon Mode D'emploi page 3

C2 CryoBalloon™ Ablation System
Description
The C2 CryoBalloon™ Ablation System is used to eliminate
unwanted tissue by application of extreme cold. The balloon
probe comes in contact with the wall of target tissue. Upon
activation by a physician using the Foot Pedal, the balloon
probe at the end of the Catheter is simultaneously cooled and
inflated with nitrous oxide, which ablates the unwanted tissue.
Nitrous oxide is fully contained within the balloon and the
system. The nitrous oxide gas exits through the proximal end
of the Catheter. The C2 CryoBalloon Ablation System is
designed for use in conjunction with a therapeutic endoscope
(3.7 mm working channel ID, 105 cm maximum working
length). The System is comprised of the following main
components:

C2 CryoBalloon™ Catheter (see Figure 1) connects to the
Controller, which controls the operation of the Catheter
such as diffuser (sprayer) positioning and ablation (nitrous
oxide release). C2 CryoBalloon Catheter consists
of proximal Connector, Catheter Connector Cap, Catheter
Shaft, balloon probe, and protective sheath. The Catheter
is supplied sterile and is available in three balloon
configurations and is disposable after single patient use.
Refer to Catheter IFU for diffuser types.
Figure 1 – C2 CryoBalloon™ Catheter
Balloon Probe
Catheter
(Distal End)
Shaft
Protective
Diffuser
Sheath
Note: Interior of catheter within the balloon utilizes a series of
printed dots and dashes on the Hypotube for positioning as shown
below. Dots are aligned to the diffuser outlet and dashes are 180°
on opposite side.
LBL-1045 Rev 12
Connector
Connector
Cap
(Proximal End)
Luer Activated
Valve
Pear Shaped
Balloon
PENTAX Medical

C2 CryoBalloon™ Controller (see Figure 2) contains the
cartridge heater and the cryogen delivery valve, which is
controlled with the Foot Pedal. The Controller contains
diffuser radial and axial positioning features that are
controlled by the Foot Pedal. The Controller is powered
by 12VDC through the Foot Pedal and is supplied non-
sterile and is reusable. An LCD touch screen on the
Controller communicates system status and allows
dosimetry input.

C2 CryoBalloon™ Cartridge (see Figure 2) containing 36
grams of nitrous oxide. The Cartridge is installed into the
Controller and replaced as required per procedure. The
Cartridge is supplied non-sterile for single patient use.
Figure 2 – C2 CryoBalloon™ Controller &
C2 CryoBalloon™ Cartridge
Cartridge
Controller
Cap
Insertion port
for Catheter
Cable
Receptacle

C2 CryoBalloon™ Foot Pedal communicates the user
input to the Controller such as diffuser positioning,
ablation, and balloon deflation. The Foot Pedal is
powered by mains with an input voltage of 90 to
264VAC, 50-60Hz at 2A. The Foot Pedal is supplied non-
sterile and is reusable.
Figure 3 – C2 CryoBalloon™ Foot Pedal
Mode Select Clockwise Rotate/
Button Distal Translation Indicator
Counter
Clockwise
Rotate/
Proximal
Translatio n
Indicator
Pedal 1
Indications for Use
The C2 CryoBalloon™ Ablation System is used
endoscopically to ablate unwanted tissue in the gastrointestinal
tract, including treatment of Barrett's oesophagus and
squamous dysplasia, by application of extreme cold.
Controller
with Cap
Control
Panel
Deflate
Button
Pedal 2 Ablation/Puff Pedal
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