truFreezeRecalls & reported problems across all models
US Endoscopy · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 6 models of truFreeze by US Endoscopy in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2023 and Sep 2, 2026 — classified as 1 injury, 19 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported truFreeze problems
Device problems
- Insufficient Device Problem Information10
- Use of Device Problem4
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Difficult to Advance1
- Infusion or Flow Problem1
- Insufficient Flow or Under Infusion1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Pain3
- Laceration(s) of Esophagus2
- Perforation2
- Abrasion1
- Crepitus1
- Laceration(s)1
truFreeze models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- truFreeze 2000181UNIT, CRYOSURGICAL, ACCESSORIES6 reports
- truFreeze 2000177UNIT, CRYOSURGICAL, ACCESSORIES6 reports
- truFreeze 2000516UNIT, CRYOSURGICAL, ACCESSORIES4 reports
- truFreeze CO8407030501UNIT, CRYOSURGICAL, ACCESSORIES2 reports
- truFreeze CC301UNIT, CRYOSURGICAL, ACCESSORIES1 report
- truFreeze 2000184UNIT, CRYOSURGICAL, ACCESSORIES1 report
Recent truFreeze adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 2, 2026Insufficient Device Problem Information
Patient problems: Abrasion
MAUDE report 50570548 ↗MalfunctionApr 9, 2026Break
THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT, "PREPPING FOR CRYO CASE, TRUFREEZE CATHETER CAME BROKEN IN PACKAGE AND HAD TO BE REPLACED. TECHNICIAN NOTED PRIOR TO USE THAT THE WHITE CATHETER SECTION WAS BROKEN FROM THE BLACK SECTION". NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831399 ↗MalfunctionFeb 4, 2026Break
THE USER FACILITY REPORTED THAT THE WIRE OF THEIR ACTIVE VENTING CRYO DECOMPRESSION TUBE "POKED" THE PATIENT DURING A PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ACTIVE VENTING CRYO DECOMPRESSION TUBE. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261044 ↗MalfunctionJan 2, 2026Leak/Splash
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ACTIVE VENTING SPRAY CATHETER BEGAN TO LEAK AFTER IT WAS CONNECTED TO THE TRUFREEZE CONSOLE AND THE CRYO FOOT PEDAL WAS ACTIVATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY USING A PULMONARY CATHETER. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23946471 ↗MalfunctionNov 21, 2025Mechanical Problem; Mechanical Problem
THE USER FACILITY REPORTED THAT THE GUIDEWIRE OF THE ACTIVE VENTING CRYO DECOMPRESSION TUBE WENT THROUGH THE SHEATH CAUSING A SMALL CUT TO THE PATIENT'S ESOPHAGUS. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR ANOTHER DAY.
Patient problems: Laceration(s) of Esophagus
MAUDE report 23622455 ↗MalfunctionJul 25, 2025Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A STIFFENING WIRE, NORMALLY INTERNAL TO THE ACTIVE VENTING CRYO DECOMPRESSION TUBE, BECAME EXPOSED. AS A RESULT, THE PATIENT OBTAINED MUCOSAL DAMAGE IN THE UPPER ESOPHAGEAL SPHINCTER FROM THE EXPOSED WIRE. THE PATIENT WAS TREATED WITH A LIDOCAINE RINSE. THE PROCEDURE WAS DISCONTINUED AND RESCHEDULED AND COMPLETED SUCCESSFULLY AT A LATER DATE .
Patient problems: Laceration(s) of Esophagus
MAUDE report 22612538 ↗MalfunctionApr 17, 2025Difficult to Advance; Difficult to Advance
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE TWO WIRES OF THEIR CRYO DECOMPRESSION TUBE WERE EXPOSED AND RESISTANCE WAS FELT BY USER FACILITY PERSONNEL WHILE OPERATING THE TUBE. USER FACILITY PERSONNEL ATTEMPTED TO STRAIGHTEN OUT THE WIRING OF THE TUBING BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY USING ANOTHER DEVICE. UPON COMPLETION OF THE PROCEDURE, CREPITUS WAS NOTICED ON THE BACK OF THE PATIENT'S NECK. MEDICAL TREATMENT WAS ADMINISTERED TO REMOVE THE CREPITUS; HOWEVER, IT IS UNKNOWN WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Crepitus
MAUDE report 21857508 ↗MalfunctionSep 18, 2024
WHEN USING CRYO CATHETER, YOU MUST SCAN THE RAPID AV VENTING CATHETER PACKAGE BEFORE LIQUID NITROGEN WILL BE RELEASED. PACKAGE WOULD NOT SCAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20245651 ↗MalfunctionAug 29, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING TWO PATIENT PROCEDURES, THE RAPID AV CATHETER BROKE IN THE CHANNEL OF THE SCOPE. FOLLOWING A DELAY, USER FACILITY PERSONNEL UTILIZED ANOTHER CATHETER TO COMPLETE THE PATIENT PROCEDURES. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20099833 ↗MalfunctionJul 12, 2024Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT THREE OF THEIR RAPID AV SPRAY CATHETERS WOULD NOT SPRAY PROPERLY RESULTING TO A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19731411 ↗MalfunctionJun 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT THEIR TRUEFREEZE CONSOLE WAS UNABLE TO SCAN THE CATHETER POUCH SUCCESSFULLY. THE CUSTOMER COMPLETED PROCEDURE WITH ANOTHER CATHETER, SUBSEQUENTLY CAUSING THE PATIENT PROCEDURE TO BE DELAYED. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19516180 ↗MalfunctionJun 8, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT DURING A TRUFREEZE SPRAY CRYOTHERAPY PROCEDURE, WIRES INSIDE THEIR CRYO DECOMPRESSION TUBE LOOSENED AND BEGAN TO PULL OUT OF THE TUBE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19493596 ↗MalfunctionFeb 15, 2024Insufficient Flow or Under Infusion; Insufficient Device Problem Information; Insufficient Flow or Under Infusion; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR AIRE PASSIVE VENTING CATHETER WAS NOT SPRAYING EVENLY RESULTING IN A 10-MINUTE PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712606 ↗MalfunctionOct 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT A SMALL LINEAR TEAR WAS DETECTED IN A PATIENT WHILE UNDERGOING A PROCEDURE WHICH INCLUDED USE OF TRUFREEZE CRYOSPRAY THERAPY. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE PATIENT (CHEST TUBE AND HOSPITALIZATION).
Patient problems: Laceration(s)
MAUDE report 17958878 ↗MalfunctionJul 27, 2023Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT AN EMPLOYEE ATTEMPTED TO STOP THEIR TRUFREEZE CONSOLE FROM ROLLING OFF THE LOADING DOCK, INJURING THE EMPLOYEE'S BACK AND ARM. THE EMPLOYEE STATED THAT ONE OF THE WHEELS FELL OFF THEIR TRUFREEZE CONSOLE. MEDICAL TREATMENT WAS SOUGHT, BUT THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS ADMINISTERED.
Patient problems: Pain
MAUDE report 17404818 ↗
Other US Endoscopy products
All US Endoscopy devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page