MAUDE Adverse Event Report: US ENDOSCOPY TRUFREEZE; CRYO DECOMPRESSION TUBE

Model Number	2000181
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, it was discovered that user facility personnel were attempting to use forceps and a snare to pull the decompression tube subject of the reported event into a lower position within the stomach cavity.This method is contrary to the instructions for use, which describes use of guidewire exchange for decompression tube positioning.Pulling with the forceps and a snare likely stretched the decompression tube, allowing the stiffening wire to protrude from the device, and subsequently causing the reported event.The active venting cryo decompression tube ifu states "for the 16 fr cdt (2000181): a guidewire should be used to aid in cdt placement using a standard endoscope/guidewire exchange technique.The four black bands on the cdt should be placed at the gej if using in the esophagus.A minimum of one (1) band should be visible from above the gej.Note: when used in areas other than esophagus (i.E.Stomach, rectum or colon) cdt black bands should be placed approximately 1 cm past the treatment zone.Note: when routing the cdt outside the patient's oral cavity, leave slack in the cdt to prevent tube kinking.6.Remove guidewire from cdt and attach the free end of the suction tubing to the cdt.7.Place optional distal attachment cap on end of the endoscope.8.Re-intubate the patient with the endoscope to confirm cdt black bands are properly aligned then secure cdt in place." steris offered in-service training on the proper use and operation of the active venting cryo decompression tube, however the user facility declined.No additional issues have been reported.
Event or Problem Description
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.

• Brand Name: TRUFREEZE
• Common Device Name: CRYO DECOMPRESSION TUBE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4405197842
• MDR Report Key: 22612538
• Report Number: 1528319-2025-00078
• Device Sequence Number: 18576282
• Product Code: GEH
• UDI-Device Identifier: 00724995199210
• UDI-Public: (01)00724995199210(11)240901(17)260901(10)4523
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K223369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2026
• Device Model Number: 2000181
• Device Catalogue Number: 2000181
• Device Lot Number: (10)4523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown