truFreeze CD3-001 (REF C08407030500)Recalls & reported problems
Csa Medical, Inc. · Active Venting Spray Kit 5 Active Venting Cryo Decompression Tube 5 Active Venting Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857068006044), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Injury1
- Internal Organ Perforation1
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS EVENT OCCURRED IN (B)(6) 2018. THE PATIENT IS A (B)(6)-YEAR-OLD MAN WITH BARRETT'S ESOPHAGUS WITH HIGH-GRADE DYSPLASIA AS WELL AS WELL-COMPENSATED CIRRHOSIS DUE TO HEPATITIS C. HE WAS TREATED WITH SUBOXONE FOR CHRONIC PAIN. THE DR. CHOSE CRYOTHERAPY TO AVOID THE PAIN ASSOCIATED WITH USING RADIOFREQUENCY ABLATION. A PREVIOUS CRYOTHERAPY SESSION HAD BEEN PERFORMED WITHOUT INCIDENT. ENDOSCOPY AT THIS SESSION SHOWED A "DRAMATIC RESPONSE" OF THE BARRETT'S ESOPHAGUS TISSUE TO THE FIRST CRYOTHERAPY SESSION. THE ENDOSCOPY AND CRYOTHERAPY TREATMENT PROCEEDED WITHOUT INCIDENT UP UNTIL THE SAE OCCURRED. INSUFFLATION AT THIS ENDOSCOPY USED CARBON DIOXIDE. THIS WAS THE FIRST CASE USING THE RAPID AV CATHETER AND 16 FRENCH CRYO-DECOMPRESSION TUBE FOR THE DR. THE DR. SET UP THE EQUIPMENT AND PLACED IN THE CRYO-DECOMPRESSION TUBE IN THE USUAL MANNER. THE FIRST 20 SECOND CRYO-SPRAY PROCEEDED WITHOUT PROBLEM. ON THE SECOND SPRAY, TREATMENT WAS DISCONTINUED DUE TO ABDOMINAL DISTENTION DETECTED BY THE NURSE MONITORING THE PATIENT. THE EQUIPMENT, INCLUDING THE DECOMPRESSION TUBE, APPEARED TO BE FUNCTIONING NORMALLY THROUGH THE PROCEDURE. NO ALARMS SOUNDED FORM THE CONSOLE DURING THE PROCEDURE. DUE
Patient problems: Injury; Internal Organ Perforation; Perforation
MAUDE report 8815499 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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