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ADVERSE EVENTS
The potential adverse events associated with the device and/or cryoablation procedure include, but are not limited to:
• Angina
• Arrhythmia
• Atelectasis
• Bladder spasms
• Bleeding/hemorrhage
• Burn/frostbite
• Cerebrovascular Accident (CVA)/stroke
• Cryoshock Phenomenon (e�g� multi organ failure, severe coagulopathy, disseminated intravascular coagulation
(DIC))
• Death
• Distension
• Edema/swelling
• Ejaculatory dysfunction
• Embolism (air, device, thrombus)
• Erectile dysfunction
• Fever
• Fistula
• Fracture
• Gastrointestinal symptoms (e�g� nausea, vomiting, diarrhea, constipation)
• Healing, impaired
• Hematoma
• Hematuria
• Hemothorax
• Hepatic dysfunction/failure
• Hernia
• Hypertension
• Hypotension
• Hypothermia
• Ileus
• Impotence
• Infection/abscess/sepsis
• Inflammation
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Black (K) ∆E ≤5.0
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