MAUDE Adverse Event Report: CRYOSURGERY, INC. Verruca-Freeze; CRYOSURGICAL UNIT

Model Number	VFC65
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, a licensed healthcare professional used a verruca-freeze cryosurgical system (lot vf2531502) to treat a large wart on the finger of a 14-year-old patient at a pediatric clinic.The practitioner selected a 9mm cryocone applicator, pressed it to create a seal, and sprayed cryogen against the inside of the cryocone.Cryogen leaked outside the cryocone onto the patient's finger and through a towel onto the patient's thigh.Both areas became pink and were rinsed.The thigh became slightly raised shortly after.A thin layer of petroleum jelly was applied to both areas.By the following day, the patient developed large blisters on the finger requiring care at a burn hospital.The patient was diagnosed with a partial thickness burn on the finger requiring debridement and is receiving ongoing burn hospital follow-up.A first degree burn on the thigh is healing without complication.
Additional Manufacturer Narrative
Investigation determined the cryocone applicator was used contrary to ifu guidance, which specifies cryobud applicators for hands and bony areas.Device not returned for evaluation.Root cause: incorrect applicator selection.Remedial action: ifu revision to add explicit contraindication for cryocone use on bony areas.

• Brand Name: Verruca-Freeze
• Common Device Name: CRYOSURGICAL UNIT
• Manufacturer (Section D): CRYOSURGERY, INC.; 5829 old harding pike; nashville TN 37205
• Manufacturer (Section G): CRYOSURGERY, INC.; 5829 old harding pike; nashville TN 37205
• Manufacturer Contact: kaitlyn clements ; 5829 old harding pike; nashville, TN 37205 ; +1(615)354-0414
• MDR Report Key: 50279546
• Report Number: 1056356-2026-00001
• Device Sequence Number: 10068430
• Product Code: GEH
• UDI-Device Identifier: 00865715000307
• UDI-Public: (01)00865715000307(10)VF2531502
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K982506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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 Model Number: VFC65
• Device Lot Number: VF2531502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female