Ablation systems
C2 CryoBalloon Ablation System
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
C2 CryoBalloon Ablation System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| FG-1025 | — | Not stated | Available |
| FG-1029 | — | Not stated | Available |
Procedures that use ablation systems
Frequently asked questions
What is C2 CryoBalloon Ablation System used for?
A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.
Who makes C2 CryoBalloon Ablation System?
C2 CryoBalloon Ablation System is made by Pentax of America, Inc.. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does C2 CryoBalloon Ablation System come in?
The FDA device database does not list sizes for C2 CryoBalloon Ablation System. Check the instructions for use or ask a Pentax of America, Inc. representative.
Is C2 CryoBalloon Ablation System MRI safe?
The FDA device database entry for C2 CryoBalloon Ablation System does not state its MRI safety status. Check the labeling before MRI.
Is C2 CryoBalloon Ablation System FDA cleared?
C2 CryoBalloon Ablation System is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Pentax of America, Inc. sales representative?
Pentax of America, Inc. has not listed representatives on LA Vascular yet. Visit the Pentax of America, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.