# K240457: C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Jul 24, 2024 after 159 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212814: C2 CryoBalloon Ablation System, Pentax of America, Inc. (2021) Summary page 4.

## Indications for use
The C2 CryoBalloon™ Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett’s Esophagus with dysplasia and treatment and management of Gastric Antral Vascular Ectasia (GAVE).

Source page: https://510kreport.com/device/K240457
Methodology: https://510kreport.com/methodology